Apparatus and method for steering a guidewire and connecting to an extension guidewire

ABSTRACT

An apparatus for steering a guidewire and for connecting the guidewire to an extension guidewire. The apparatus includes a steering device for gripping an exterior of the guidewire, the steering device defining a passageway therein through which the guidewire may pass; and a connecting device for connecting the guidewire to the extension guidewire. The connecting device is configured for mating with the steering device to form an integral unit. The invention further includes a method of inserting a guidewire in a body and connecting the guidewire to an extension guidewire. The method includes the steps of: providing an integral guidewire holder and tool for connecting a guidewire to an extension guidewire; gripping the guidewire with the integral guidewire holder; inserting the guidewire into a body lumen; displacing the integral guidewire holder and tool relative to the guidewire so that the proximal end of the guidewire is located in a slot of the integral guidewire holder and tool; inserting an extension guidewire into the slot of the integral guidewire holder and tool; and connecting the guidewire to the extension guidewire. The method further includes the step of aligning the guidewire and extension guidewire in the slot prior to the connecting step.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to an apparatus and method for manipulating aguidewire and connecting the guidewire to an extension guidewire.

2. Description of the Related Art

Medical guidewires generally are used for navigating through internalpassageways of a body. The distal end of a guidewire is introduced intoa body by a physician through an opening in the body. The physicianmanipulates the tip of the guidewire through the body to a site to betreated. A catheter or other medical device is usually advanced over theguidewire to the treatment site. In some medical applications, it isdesirable to use multiple catheters sequentially in order to completethe medical procedure. When it is necessary to change catheters, it isusually preferred that the catheter be removed in a manner which enablesa guidewire to remain in place in the body so that the end of theguidewire remains on the site to be treated. In order to maintain aguidewire in place while withdrawing the catheter, the guidewire must begripped at its proximal end to prevent it from being pulled away fromthe site to be treated, for example, a blood vessel. However, theguidewire typically only extends for a short portion outside of thecatheter which is inserted in the body. Therefore, before the catheteris fully withdrawn from the body, the catheter completely covers theproximally extending end of the guidewire. As a result, there is no wayin which to grip the proximal end of the guidewire to hold it in placeand prevent it from being withdrawn together with the catheter.

One method which has been proposed for solving the above catheterexchange problem is the use of an exchange wire. In such a method, theexisting guidewire is removed and replaced by a longer exchange wire.The removal and replacement occurs with the existing catheter in place.Unfortunately, the insertion of each additional wire significantlyincreases the risk of trauma and puncture to the patient and extends theduration of the procedure.

Another common method is the use of an extension guidewire. This hasimproved the procedure for performing a catheter exchange. An extensionguidewire allows a catheter exchange to be made without any guidewireexchanges. In this way, there is a significant reduction in risk ofpuncturing blood vessels in the body, and a reduction in the time toperform the procedure. However, current apparatus and methods forsteering the main guidewire into the body and then connecting the mainguidewire to an extension guidewire to perform a catheter exchange havecertain drawbacks.

Current extension guidewire methods require the use of a separateapparatus for steering the main guidewire into the body and a separateapparatus for aligning and connecting the main guidewire with anextension guidewire. Typically, a torque vise or pin vise is providedfor gripping the main guidewire and steering the main guidewire into thehuman body. The main guidewire is often provided with an angled tip sothat the operator can rotate the main guidewire and steer the mainguidewire through the body. The torque vise can be slid back along themain guidewire to permit advancement of the main guidewire relative tothe torque vise in order to insert the main guidewire further into thehuman body. Once the main guidewire and catheter are in place, it isoften necessary to perform a catheter exchange.

Typically, an alignment tool functions to connect the proximal end ofthe in-situ guidewire to an extension guidewire. The torque vise isfirst removed from the in-situ guidewire. The alignment tool is thenplaced on the in-situ guidewire and used to align and connect thein-situ guidewire with an extension guidewire. After the in-situguidewire and extension guidewire are connected, the alignment tool isremoved. The alignment tool is removed by sliding the alignment toolproximally over the portion of the in-situ guidewire located in thealignment tool and then over the extension guidewire. The existingcatheter in the body is then drawn proximally over the entire length ofthe in-situ and extension guidewire, and then replaced by a new catheterby sliding the new catheter distally over the entire length of theextension guidewire and in-situ guidewire. The extension guidewire thencan be disconnected once the new catheter is in place.

This process of using a separate torque vise and alignment tool iscumbersome and significantly increases the amount of time for performingsuch operations. The amount of time spent on such operations cansignificantly increase the risk to a patient. Moreover, the use ofseparate apparatus for steering the main guidewire and for connectingthe main guidewire to an extension guidewire makes the operation morecomplex, thus leading to more opportunities for mistakes or movement ofthe in-situ main guidewire during a catheter exchange. In addition, eachtool must be separately manufactured, packaged and handled, increasingcost, for example. Therefore, for the above reasons, the currentapparatus and methods for steering a main guidewire and connecting themain guidewire to an extension guidewire are less than desirable. Thereis a need for an apparatus and method for steering a main guidewire andconnecting the main guidewire to an extension guidewire whichsubstantially obviates these problems.

SUMMARY OF THE INVENTION

The advantages and purposes of the invention will be set forth in partin the description which follows, and in part will be obvious from thedescription, or may be learned by practice of the invention. Theadvantages and purposes of the invention will be realized and attainedby means of the elements and combinations particularly pointed out inthe appended claims.

To attain the advantages and in accordance with the purposes of theinvention, as embodied and broadly described herein, the inventionincludes an apparatus for steering a guidewire and for connecting theguidewire to an extension guidewire. The apparatus includes a steeringdevice for gripping an exterior of the guidewire, the steering devicedefining a passageway therein through which the guidewire may pass, anda connecting device for connecting the guidewire to the extensionguidewire. The connecting device is configured for mating with thesteering device to form an integral unit.

In another aspect, the invention includes a method of inserting aguidewire into a body and connecting the guidewire to an extensionguidewire. The method includes the steps of: providing an integralguidewire holder and tool for connecting a guidewire to an extensionguidewire; gripping the guidewire with the integral guidewire holder;inserting the guidewire into a body lumen using the integral guidewireholder and tool; displacing the integral guidewire holder and toolrelative to the guidewire so that the proximal end of the guidewire islocated in a slot of the integral guidewire holder and tube; insertingan extension guidewire into the slot of the integral guidewire holderand tool; and connecting the guidewire to the extension guidewire.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory onlyand are not restrictive of the invention, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate several embodiments of theinvention and together with the description, serve to explain theprinciples of the invention. In the drawings,

FIG. 1 is a side view of an apparatus for steering a guidewire and forconnecting the guidewire to an extension guidewire according to anembodiment of the invention;

FIG. 2 is a top view of the apparatus of FIG. 1 with a guidewireinserted therethrough;

FIG. 3 is a side view of a steering device of the apparatus of FIG. 1;

FIG. 4 is a side view of the steering device of FIG. 3 with portionsremoved;

FIG. 5 is an end view of the steering device of FIG. 3;

FIG. 6 is a cross-sectional view of the steering device of FIG. 3, takenalong line VI-VI of FIG. 5;

FIG. 7 is a top view of a connecting device of the apparatus of FIG. 1;

FIG. 8 is a side view of the connecting device of FIG. 7;

FIG. 9 is a perspective view of the connecting device of FIG. 7; and

FIG. 10 is an end view of the connecting device of FIG. 7.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Reference will now be made in detail to the present preferredembodiments of the invention, examples of which are illustrated in theaccompanying drawings. Wherever possible, the same reference numberswill be used throughout the drawings to refer to the same or like parts.

Throughout the specification and claims, the terms “proximal” and“distal” are used to designate relative ends of components. These termsare used in the same manner in which they are widely used and wellrecognized by those knowledgeable in the field of medical procedures.The “distal” end of the components refers to the end furthest inside thebody when in use and therefore furthest from the operator of thecatheter or guidewire, whereas “proximal” end refers to the oppositeend, i.e., the end closest to the operator.

In accordance with the present invention, an apparatus for steering aguidewire and for connecting the guidewire to an extension guidewire isprovided. According to an embodiment of the invention, the apparatusgenerally includes a steering device and a connecting device. Thesteering device grips an exterior of the guidewire in order to steer theguidewire. The steering device defines a passageway therein throughwhich a guidewire may pass. The connecting device connects the guidewireto an extension guidewire. The connecting device is configured formating with the steering device to form a single integral unit. A methodof steering the guidewire and connecting the guidewire to an extendableguidewire is also provided.

The apparatus for performing steering of a guidewire and connecting theguidewire to an extension guidewire will be described below. As embodiedherein and shown in FIGS. 1-10, the apparatus 10 for steering aguidewire 100 and for connecting the guidewire to an extension guidewireincludes a steering device 12 and a connecting device 14. The apparatus10 is a single, integral unit which can be used for both steering aguidewire through lumens of a body, and for connecting an extensionguidewire to the in-situ guidewire in order to perform a catheterexchange. With the present invention, it is not necessary to completelyremove a torque vise from the guidewire prior to aligning and connectingthe guidewire with an extension guidewire, as will be apparent from thefollowing description. The provision of the steering device andconnecting device into a single, integral unit simplifies the procedurefor exchanging catheters, making the procedure quicker, safer, and lessexpensive.

In accordance with the present invention, the steering device manuallygrips the exterior of a guidewire in order to steer the guidewirethrough the body. As embodied herein and shown in FIGS. 1-6, theguidewire steering device 12 holds or grips an exterior of a guidewire100. A guidewire steering device or guidewire holder can be any suitabledevice for holding onto a guidewire so that it can be manipulatedthrough the body. In the specific embodiment shown in the drawings, theguidewire steering device or guidewire holder is a torque device oftenreferred to as a torque vise or pin vise.

The steering device 12 comprises a distal outer tubular member 15 and aninner member 18. The distal outer tubular member 15 includes a proximalgripping portion 16 and a distal prong-engaging portion 17. The proximalgripping portion 16 has grooves on the outer periphery thereof forenhancing the ability of the operator to grip the distal outer tubularmember 15. The distal prong-engaging portion 17, in one embodiment, hasa smaller diameter than the proximal gripping portion. The details ofthe distal outer tubular member 15 will be described below in relationto the inner member 18.

The inner member 18 includes a proximal cylindrical portion 20, acentral cylindrical portion 22, a distal cylindrical portion 24, and aplurality of longitudinal prongs 26. As shown in FIGS. 4-6, the proximalcylindrical portion 20 has a greater diameter than the central anddistal cylindrical portions 22 and 24, while the distal cylindricalportion 24 has a greater diameter than the central cylindrical portion22. The distal outer tubular member 15 and the inner member 18 share acommon axis and are slidable relative to one another. The distal outertubular member 15 is positioned around the exterior of at least aportion of the central cylindrical portion 22, distal cylindricalportion 24, and the plurality of longitudinal prongs 26. The proximalgripping portion 16 of the distal outer tubular member 15 is primarilylocated around central cylindrical portion 22 and distal cylindricalportion 24.

The distal prong-engaging portion 17 of the distal outer tubular member15 is located around the plurality of longitudinal prongs 26. The innerdiameter of the distal prong-engaging portion 17 is configured to beslightly larger than the outside diameter of the plurality oflongitudinal prongs 26 at the distal end of the prongs, but smaller thanthe outside diameter of the plurality of longitudinal prongs 26 at theproximal end of the prongs. Therefore, the axial sliding of the distalouter tubular member 15 in the proximal direction (to the right in FIGS.1-2) causes the inner diameter of the distal prong-engaging portion 17to interfere with the outer diameter of the plurality of longitudinalprongs 26. As the distal outer tubular member 15 is gradually slidfarther in the proximal direction, the inner diameter of distal tubularmember 15 will squeeze against the longitudinal prongs 26 to force theprongs to bend or compress toward each other. The bending andcompressing narrows the gap between the prongs 26, ultimately forcingprongs 26 against guidewire 100 which is inserted inside a longitudinalpassage 28 inside steering device 12. The mechanical manipulation of thedistal outer tubular member 15 in the proximal direction will providesufficient gripping force to secure the steering device 12 and guidewire100 together in fixed relation to one another so that guidewire 100 canbe steered through the human body. The manipulation of the distal outertubular member 15 in the distal direction will release the grip of thelongitudinal prongs 26 on guidewire 100, and allow for relative movementbetween the steering device and guidewire 100.

The scope of the present invention includes types of guidewire steeringdevices other than the torque-vise type device shown and described. Forexample, many different torque devices, such as a pin-vise with a chuckcollet, exist where an outer member is rotated relative to an innermember in order to tighten or widen a plurality of longitudinal prongssimilar to those shown in FIGS. 1-6. The type of torque device is notessential as long as the torque device is configured for mating with analignment and connecting device of the present invention. Many torquevises have an open area on the proximal end capable of accepting analignment and connecting device of the present invention.

The steering device of the present invention is configured for matingwith an alignment and connecting device as will be described below. Asshown in FIG. 6, the longitudinal passage 28 of the present embodimenttapers to becomes progressively larger along the central cylindricalportion 22 moving in the proximal direction (to the right in FIG. 6).The longitudinal passage 28 includes a conical passage 30 inside thecentral cylindrical portion 22. The conical passage 30 leads to aproximal passage 32 adjacent the proximal cylindrical passage 20. Theproximal passage 32 includes a frustoconical section 33 at its mostdistal end adjacent passage 30, and a cylindrical portion 34 at theproximal end of section 33. Portion 34 includes a slight taper at aproximal portion 36. The diameter of the proximal portion 36 increasesprogressively towards the proximal end of the steering device 12. Theproximal passage 32 is configured to mate with an alignment andconnection tool, as will be described. It should be understood that thescope of the present invention includes any suitable configuration formating the steering device with the alignment and connecting device isacceptable.

In accordance with the present invention, the apparatus for steering aguidewire and for connecting the guidewire to an extension guidewireincludes an alignment and connecting device. As embodied herein andshown in FIGS. 1-2 and 7-10, an alignment and connecting device 14 foraligning and connecting the guidewire to an extension guidewire isprovided. The connecting device 14 includes an attachment portion 50configured for attaching the connecting device 14 to the guidewiresteering device 12 to form a single unit, and an alignment portion 52for aligning the guidewire with an extension guidewire.

The attachment portion 50 of the connecting device 14 is configured tomate with the proximal passage 32 of the guidewire steering device 12.The attachment portion 50 is generally cylindrical shaped with twocylindrical portions 54 and 56. The first cylindrical portion 54 extendsfrom the alignment portion 52 of the connecting device 14. The secondcylindrical portion 56 extends from the first cylindrical portion 54. Inthe preferred embodiment, the second cylindrical portion 56 has aslightly smaller diameter than the first cylindrical portion 54. Thesize and shape of the attachment portion can be of any of a largevariety of sizes and shapes, as long as the attachment portion mateswith a corresponding portion of the steering device. The attachmentportion 50 is preferably adhesive bonded to the proximal passage of thesteering device in order to provide a secure connection. Otheracceptable attachment methods include, but are not limited to, a solventbond, spin weld, vibration weld, and press-fitting. It is conceivablethat a number of different types of fasteners could also be utilized forattaching the connecting device to the steering device.

The method for attaching the connecting device to the steering devicedepends on a variety of design considerations, including the materialsthat are used for the connecting device and steering device. In apreferred embodiment, the connecting device and steering device are bothmade out of nylon. Other acceptable materials include, but are notlimited to, high density polyethylene, ABS (acetyl butidene styrene),various metals such as brass or stainless steel, and combinations ofmetals and plastics such as using brass prongs in a steering device witha plastic housing.

The connecting device 14 further includes an alignment portion 52. Thealignment portion includes a cylindrical portion 58 that is connected tothe attachment portion 50. In the embodiment shown in FIGS. 1-2 and7-10, the diameter of the cylindrical portion 58 is greater than thediameter of the adjacent first cylindrical portion 54 so that portion 58rests against the proximal end of the steering device. The cylindricalportion 58 of the attachment portion leads to a tapered portion 60. Thetaper is in the form of radius of a circle of a given diameter. Thetapered portion 60 leads to substantially flat surface 62. Thesubstantially flat surface 62 is located on a cutaway portion of acylinder with an identical axis and diameter as the cylindrical portion58 of the attachment portion 52. The substantially flat surface 62extends along the axis of the attachment portion 52.

The connecting device 14 further includes a cylindrical longitudinalpassage 70 which passes through the first and second cylindricalportions 54 and 56 of the attachment portion 50 and through thecylindrical portion 58 of the alignment portion 52. The longitudinalpassage 70 begins at the distal end of the second cylindrical portion56. The second cylindrical portion 56 is provided with a first conicalopening 72 for the guidewire. The first conical opening 72 makes iteasier for a guidewire to be inserted into the longitudinal passage 70if the guidewire is slightly off center from the axis of the passage 70.The conical opening 72 narrows as it progresses away from the distal endof the attachment portion until the diameter of the opening 72 matchesthe diameter of the longitudinal passage 70. It is desirable for thediameter of the longitudinal passage 70 to be slightly larger than thelargest diameter of the in-situ guidewire and extension guidewire thatwill be used.

The longitudinal passage 70 passes through the second cylindricalportion 56 of the attachment portion 50, first cylindrical portion 54 ofthe attachment portion 50, and cylindrical portion 58 of the alignmentportion 52. The longitudinal passage 70 then passes into the taperedportion 60 and flat surface 62 as best shown in FIGS. 7-10. The passage70 turns into a longitudinal slot after the tapered portion 74 of thepassage. The longitudinal slot includes a first slot 76 located adjacentthe tapered portion 74 and a second slot 78 located closer to theproximal end of the alignment portion 52. In the preferred embodiment,the longitudinal passage 70, tapered portion 74 of the passage, firstslot 76, and second slot 78 all share a common axis and have identicaldiameters. Alternative embodiments for the longitudinal slots areenvisioned and will be discussed below.

As embodied herein and shown in FIGS. 7-10, the second longitudinal slot78 leads to a second conical opening 80 on the proximal end of thealignment portion 52. The second conical opening 80 tapers outwardly inorder to facilitate insertion of the extension guidewire into theconnecting device 14. The second conical opening 80 allows for thepassage of the extension guidewire into the second longitudinal slot 78even if the extension guidewire is slightly off center from the axis ofthe slot.

As embodied herein and shown in FIGS. 2 and 7-10, a transverse channel82 is provided between the first longitudinal slot 76 and the secondlongitudinal slot 78. The transverse channel 82 extends perpendicular tothe first and second longitudinal slots 76, 78. In the preferredembodiment, the transverse channel 82 has walls of an identical height,however, other configurations are within the scope of the invention. Inthe preferred embodiment, the transverse channel 82 has a depth greaterthan the depth of the longitudinal slots, however other configurationsmay also be envisioned and still be within the scope of this invention.The transverse channel serves several purposes. First, the transversechannel 82 serves as a reference point so that it is clear to the userwhere the connection between the in-situ guidewire and extensionguidewire should be made. Second, in an embodiment where the walls ofthe transverse channel are of different heights, the higher wall mayserve as a stop for the main guidewire or extension guidewire as it isinserted into the connecting device 14. This alternate embodiment willbe discussed in the paragraph below. Lastly, the transverse channel 82provides an area in which the guidewire and extension guidewire may bemoved relative to one another to align with one another.

In one embodiment, the transverse channel has walls of differing height.This configuration would be useful in an arrangement where the mainguidewire and extension guidewire have different diameters. Thelongitudinal slot for the wire having the larger diameter will also needto be of larger diameter. As the larger diameter wire is inserted intothe alignment tool along its corresponding longitudinal slot, it willtraverse the transverse channel and abut against the farthest verticalwall of the transverse channel, thereby impeding movement of the largerdiameter wire. The end of the smaller guidewire can then be slid intothe end of the end of the larger diameter wire because the ends of thewires are aligned.

Alternately, the transverse channel may be replaced by a simple straightline marked on the top of the flat surface where the transverse channelwas previously located. This straight line will serve as a referencepoint for the operator. The operator can use the straight line as thepoint at which the guidewire should not be inserted any further into thealignment and connecting device. In an additional embodiment, thetransverse channel consists of a slot with an identical depth as thefirst and second longitudinal slots.

A variety of different types of guidewires and extension guidewires maybe used with the present invention. An exemplary type of extensionguidewire connection is shown, for example, in U.S. Pat. No. 5,133,364,to Palermo et al., the complete disclosure of which is herebyincorporated by reference herein. U.S. Pat. No. 5,133,364 describes theextension guidewire connection in greater detail. In a preferredembodiment of the present invention, the main guidewire and extensionguidewire have identical diameters. As described in U.S. Pat. No.5,133,364, the proximal end of the main guidewire may be fitted with atubular member having approximately the same outside diameter as theguidewire. The tubular member will be referred to as a hypotube becauseit is typically formed from commercially available hypodermic tubing.The hypotube typically has a wall thickness of the order of 0.003″ anddefines a cylindrical internal socket. The hypotube is considered to bepart of the main guidewire because it is essentially permanentlyattached to the proximal end of the main guidewire. The hypotube istypically welded, bonded, or brazed to the main guidewire. Othersuitable attachment methods are also acceptable.

In a preferred type of extension guidewire, the distal end of theextension guidewire has a smaller diameter than the remainder of theextension guidewire, and is provided with a helical coil on this smallerdiameter portion, as also described in U.S. Pat. No. 5,133,364. Theouter diameter of the helical coil is equal to or just slightly greaterthan the inner diameter of the cylindrical internal socket of thehypotube. This provides a light interfering fit with the socket. Themain guidewire and extension guidewire are connected by inserting thedistal end of the extension guidewire into the cylindrical internalsocket of the main guidewire and twisting. The extension guidewire canbe inserted into the guidewire as described in U.S. Pat. No. 5,133,164.The friction fit between the helical coil and the internal socket canwithstand a relatively large amount of axial tension without becomingdisconnected. However, the extension guidewire can be easilydisconnected by simply twisting the extension guidewire in theappropriate direction.

The mating ends of the main and extension guidewires may take a varietyof other structural forms known in the art and still be within the scopeof the present invention. The invention is not limited by the particularguidewire and, particularly, the particular guidewire structure forconnecting the ends. For example, the extension guidewire can bepress-fit into a cylindrical opening in the main guidewire. Alternately,the proximal end of the main guidewire and the distal end of theextension guidewire may be provided with mating geometrical shapes suchas hexagon ends.

The method of steering the guidewire and connecting the main guidewireto an extension guidewire of the present invention will now bedescribed. The method of the present invention is useful in a widevariety of medical procedures, including, for example, vascularapplications such as angioplasty and nonvascular applications such as abiliary procedure. Other procedures include cardiology procedures suchas stent placements, neuro-radiology procedures such as placement ofcoils, and urological procedures such as a catheter placement to removestones. In a biliary procedure, for example, a cannula is passed throughthe mouth into the common bile duct. The present invention can be used,for example, to insert balloon or basket catheters to remove gallstones.

The main guidewire may be steered into place in a lumen of the body byplacing the guidewire through the steering device 12 of the apparatus10. While gripping the guidewire, the steering device can be manipulatedto change the angle and speed of entry into the body. If the guidewirehas an angled tip, the guidewire can be rotated in order to change thedirection that the guidewire will follow in the body. The guidewire isthen fed from the steering device 12 by a progressive gripping andreleasing of the distal end of the steering device 12. Each gripping andreleasing will advance the guidewire slightly farther into the body. Aninitial guide catheter may already be inserted in the body, or thecatheter may be inserted over the guidewire after the guidewire hasobtained the desired position. Once a catheter is in place and it isdesirable to remove the catheter to replace it with another catheter, anextension guidewire can be connected to the in-situ guidewire.

An extension guidewire may be attached to the guidewire as follows.First, the apparatus 10 is moved proximally along the guidewire so thatit is positioned on the proximal end of the in-situ guidewire. Thein-situ guidewire is arranged so that the proximal end of the in-situguidewire passes through the longitudinal passage 28 of the steeringdevice 12 and the longitudinal passage 70 of the connection device 14.The apparatus 10 then is slid until the proximal end of the in-situguidewire is lined up with the transverse channel 82. If the transversechannel 82 has walls of varying height, the proximal end of the in-situguidewire can be positioned so that it is flush with the wall adjacentthe second longitudinal slot 78.

The steering device 12 is then clamped onto the main guidewire and theextension guidewire is inserted into the second conical opening opening80 of the connection device 14. The extension guidewire is slid alongthe second longitudinal slot 78 until the distal end of the extensionguidewire abuts and is inserted in the proximal end of the mainguidewire, or attached to the main guidewire by another method.

After the extension guidewire is connected to the main guidewire by theappropriate method, the steering device 12 may be released so that it nolonger firmly grips the main guidewire, and the apparatus 10 can be slidoff of the main guidewire and extension guidewire. The existing cathetercan then be removed by pulling the catheter over the length of the mainguidewire and extension guidewire: A new catheter may then be insertedby pushing the new catheter over the length of the extension guidewireand main guidewire. The extension guidewire can then be disconnected. Inorder to disconnect, the apparatus 10 can be fed over the length of theextension guidewire to the point just before the connection. The mainguidewire is held firm. The apparatus 10 can then be used to grip theextension guidewire so that the extension guidewire can be rotatedrelative to the main guidewire. The above steps can be repeated in orderto exchange a plurality of catheters.

It will be apparent to those skilled in the art that variousmodifications and variations can be made in the apparatus and method forsteering a guidewire and for connecting a guidewire to an extensionguidewire, use of the apparatus of the present invention, and inconstruction of this apparatus, without departing from the scope orspirit of the invention.

Other embodiments of the invention will be apparent to those skilled inthe art from consideration of the specification and practice of theinvention disclosed herein. It is intended that the specification andexamples be considered as exemplary only, with a true scope and spiritof the invention being indicated by the following claims.

1-27. (canceled)
 28. A method of connecting a guidewire to an extensionguidewire, comprising the steps of: providing an integral guidewireholder and tool for connecting a guidewire to an extension guidewire;gripping the guidewire with the integral guidewire holder and tool bymoving one portion of the integral guidewire holder and tool relative toanother portion of the integral guidewire holder and tool, wherein therelative movement is about a longitudinal axis of the guidewire;positioning the guidewire and the extension guidewire in the integralguidewire holder and tool; and connecting the guidewire to the extensionguidewire.
 29. The method of claim 28, wherein the relative movementincludes rotational movement.
 30. The method of claim 28, wherein therelative movement includes longitudinal movement.
 31. The method ofclaim 28, further comprising the step of aligning the guidewire and theextension guidewire in a slot of the integral guidewire holder and toolprior to the connecting step.
 32. The method of claim 31, wherein thestep of aligning the guidewire and the extension guidewire in the slotincludes arranging a proximal end of the guidewire and a distal end ofthe extension guidewire over a marking on a surface of the integralguidewire holder and tool.
 33. The method of claim 31, wherein the stepof aligning the guidewire and the extension guidewire in the slotincludes arranging a proximal end of the guidewire and a distal end ofthe extension guidewire over a channel of the integral guidewire holderand tool.
 34. The method of claim 33, wherein the slot extendslongitudinally in the direction of the guidewire, and the channel of theintegral guidewire holder and tool is transverse to the slot.
 35. Themethod of claim 34, wherein the step of aligning the guidewire and theextension guidewire in the slot includes abutting the proximal end ofthe guidewire against a wall of the channel and then inserting thedistal end of the extension guidewire into the proximal end of theguidewire.
 36. The method of claim 35, wherein the proximal end of theguidewire includes a hollow tubular member with a socket portion forreceiving the distal end of the extension guidewire to connect theguidewire to the extension guidewire.
 37. The method of claim 28,wherein the step of gripping the guidewire with the guidewire holder andtool further includes urging at least one prong into engagement with theguidewire.
 38. The method of claim 37, wherein the at least one prongincludes a plurality of prongs.
 39. The method of claim 28, wherein theintegral guidewire holder and tool comprises a steering device and aconnecting device, the connecting device configured for mating with thesteering device to form the integral guidewire holder and tool.
 40. Themethod of claim 39, wherein the steering device includes a passagewaytherein through which the guidewire may pass.
 41. The method of claim39, wherein the connecting device includes a longitudinal passageway.42. The method of claim 41, wherein a distal end of the connectingdevice includes a conical opening for guiding the guidewire into thelongitudinal passageway of the connecting device.
 43. The method ofclaim 41, wherein a proximal end of the connecting device includes apartial conical opening for guiding the extension guidewire intolongitudinal passageway of the connecting device.
 44. The method ofclaim 39, wherein the connecting device includes a distal end configuredto mate with a portion of the steering device.
 45. The method of claim39, wherein the connecting device includes a cylindrical outer surfaceconfigured for mating with a cylindrical inner surface of the steeringdevice.